Fracture of Head of Femur Articular Displaced, Protrusion of Intervertebral Disc, Total Knee Arthroplasty
Conditions
Brief summary
Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.
Interventions
DRUGDonepezil
Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
DRUGPlacebo
Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
Sponsors
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Tenth People's Hospital of Tongji Univeristy
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Elder than 60 years old 2. Speak Chinese Mandarin 3. Scheduled to undergo hip or knee replacement surgery and lumbar spine surgery 4. The operation time is more than 2 hours. 5. Signed the informed consent 6. American Society of Anesthesiologists (ASA) classification I-II
Exclusion criteria
1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis 2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 3. Several audition or vision disorder 4. Patients with tumors or infections 5. Unwillingness to comply with the protocol or procedures 6. Can not communicate normally in Mandarin Chinese 7. Existing bradycardiac arrhythmia (Heart rate \<60 bpm for any reasons) 8. Existing gastrointestinal ulcer 9. Existing urinary incontinence 10. Existing asthma or chronic obstructive pulmonary disease 11. Postoperative admission to ICU 12. Allergic to donepezil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of POCD after the surgery. | up to 7 days |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of postoperative delirium after surgery. | 1 to 7 days after surgery |
| POCD incidence one month, six months and one year after surgery. | one month, six months and one year after surgery |
Countries
China
Contacts
Primary ContactDiansan Su, M.D., Ph.D.
Outcome results
None listed